SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

SECTION 1. IDENTIFICATION
Product name:

Estradiol Gel Formulation

Manufacturer or supplier's details
Company name of supplier: Organon & Co.
Address: 30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302
Telephone: 1-551-430-6000
Emergency telephone: 1-215-631-6999
E-mail address: EHSSTEWARD@organon.com
Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
SECTION 2. HAZARDS IDENTIFICATIONGHS classification in accordance with the OSHA Hazard Communication Standard (29 CFR
1910.1200)
Flammable liquids: Category 2
Eye irritation:

Category 2ACarcinogenicity:

Category 1A

Reproductive toxicity:

Category 1ASpecific target organ toxicity- repeated exposure:

Category 1 (Liver, Bone, Blood, Endocrine system)

GHS label elements
Hazard pictograms:

Signal Word:

DangerHazard Statements:

H225 Highly flammable liquid and vapor.
H319 Causes serious eye irritation.
H350 May cause cancer.
H360FD May damage fertility. May damage the unborn child.
H372 Causes damage to organs (Liver, Bone, Blood, Endocrine
system) through prolonged or repeated exposure.

Precautionary Statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
1 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

P210 Keep away from heat, sparks, open flame and hot surfaces. No smoking.
P233 Keep container tightly closed.
P241 Use explosion-proof electrical, ventilating and lighting
equipment.
P242 Use only non-sparking tools.
P243 Take precautionary measures against static discharge.
P260 Do not breathe vapors.
P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves, protective clothing, eye protection
and face protection.
Response:
P303 + P361 + P353 IF ON SKIN (or hair): Take off immediately
all contaminated clothing. Rinse skin with water.
P305 + P351 + P338 IF IN EYES: Rinse cautiously with water
for several minutes. Remove contact lenses, if present and easy
to do. Continue rinsing.
P308 + P313 IF exposed or concerned: Get medical attention.
P337 + P313 If eye irritation persists: Get medical attention.
Storage:
P403 + P235 Store in a well-ventilated place. Keep cool.
P405 Store locked up.
Disposal:
P501 Dispose of contents and container to an approved waste
disposal plant.
Other hazards
Vapors may form explosive mixture with air.
SECTION 3. COMPOSITION/INFORMATION ON INGREDIENTS
Substance / Mixture:

MixtureComponents
Chemical name
Ethanol#
Propylene glycol
Estradiol# Voluntarily-disclosed substance

CAS-No.
64-17-5
57-55-6
50-28-2

Concentration (% w/w)
58.5
12.5
0.1

SECTION 4. FIRST AID MEASURES
General advice:

In the case of accident or if you feel unwell, seek medical
advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.

If inhaled:

If inhaled, remove to fresh air.
Get medical attention.
2 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

In case of skin contact:

In case of eye contact:

If swallowed:

Most important symptoms
and effects, both acute anddelayed:Protection of first-aiders:

Notes to physician:

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of contact, immediately flush eyes with plenty of water
for at least 15 minutes.
If easy to do, remove contact lens, if worn.
Get medical attention.
If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Causes serious eye irritation.
May cause cancer.
May damage fertility. May damage the unborn child.
Causes damage to organs through prolonged or repeatedexposure.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).
Treat symptomatically and supportively.

SECTION 5. FIRE-FIGHTING MEASURES
Suitable extinguishing media:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemicalHigh volume water jet

Unsuitable extinguishingmedia
Specific hazards during firefighting::

Do not use a solid water stream as it may scatter and spread
fire.
Flash back possible over considerable distance.
Vapors may form explosive mixtures with air.
Exposure to combustion products may be a hazard to health.

Hazardous combustion products:

Carbon oxides

Specific extinguishing methods:

Special protective equipment
for fire-fighters:

Use extinguishing measures that are appropriate to local circumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
In the event of fire, wear self-contained breathing apparatus.
Use personal protective equipment.

SECTION 6. ACCIDENTAL RELEASE MEASURES
Personal precautions, protec- :tive equipment and emergency procedures

Remove all sources of ignition.
Ventilate the area.
Use personal protective equipment.
3 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Follow safe handling advice (see section 7) and personal
protective equipment recommendations (see section 8).
Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Prevent spreading over a wide area (e.g., by containment or
oil barriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials forcontainment and cleaning up:

Non-sparking tools should be used.
Soak up with inert absorbent material.
Suppress (knock down) gases/vapors/mists with a water sprayjet.
For large spills, provide diking or other appropriate
containment to keep material from spreading. If diked material
can be pumped, store recovered material in appropriate
container.
Clean up remaining materials from spill with suitable
absorbent.
Local or national regulations may apply to releases anddisposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need todetermine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

SECTION 7. HANDLING AND STORAGE
Technical measures:

Local/Total ventilation:

Advice on safe handling:

Conditions for safe storage:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Use explosion-proof electrical, ventilating and lighting equipment.
Do not get on skin or clothing.
Do not breathe vapors.
Do not swallow.
Do not get in eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure
assessment
Non-sparking tools should be used.
Keep container tightly closed.
Keep away from heat, hot surfaces, sparks, open flames andother ignition sources. No smoking.
Take precautionary measures against static discharges.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
Keep in properly labeled containers.
4 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

Materials to avoid

SDS Number:
10608695-00006:

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Store locked up.
Keep tightly closed.
Keep in a cool, well-ventilated place.
Store in accordance with the particular national regulations.
Keep away from heat and sources of ignition.
Do not store with the following product types:
Strong oxidizing agents
Self-reactive substances and mixtures
Organic peroxides
Flammable solids
Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures which in contact with water emit
flammable gases
Explosives
Gases
Very acutely toxic substances and mixtures

SECTION 8. EXPOSURE CONTROLS/PERSONAL PROTECTION
Ingredients with workplace control parameters
Components

CAS-No.

Ethanol

64-17-5

Value type
(Form ofexposure)
STEL
TWA
TWA

Propylene glycol
Estradiol57-55-6
50-28-2

TWA
TWA

Further information: Skin
Wipe limit
Engineering measures:

Control parameters / Permissible
concentration
1,000 ppm
1,000 ppm
1,900 mg/m³
1,000 ppm
1,900 mg/m³
10 mg/m³
0.05 µg/m3 (OEB
5)

Basis

0.5 µg/100 cm²Internal

ACGIH
NIOSH REL
OSHA Z-1
US WEELInternal

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and toprevent leakage of compounds into the workplace.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
No open handling permitted.
Totally enclosed processes and materials transport systems
are required.
Operations require the use of appropriate containment
technology designed to prevent leakage of compounds into
the workplace.
Use explosion-proof electrical, ventilating and lighting
equipment.

5 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Personal protective equipment
Respiratory protection: General and local exhaust ventilation is recommended tomaintain vapor exposures below recommended limits. Where
concentrations are above recommended limits or are
unknown, appropriate respiratory protection should be worn.
Follow OSHA respirator regulations (29 CFR 1910.134) anduse NIOSH/MSHA approved respirators. Protection provided
by air purifying respirators against exposure to any
hazardous chemical is limited. Use a positive pressure air
supplied respirator if there is any potential for uncontrolled
release, exposure levels are unknown, or any othercircumstance where air purifying respirators may not provide
adequate protection.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Eye protection:

Skin and body protection:

Hygiene measures:

Consider double gloving. Take note that the product isflammable, which may impact the selection of handprotection.
Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets,
disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
If exposure to chemical is likely during typical use, provide
eye flushing systems and safety showers close to theworking place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

SECTION 9. PHYSICAL AND CHEMICAL PROPERTIES
Appearance

:

gel

Color

:

opalescent

Odor

:

aromatic

Odor Threshold:

No data available

pH:

No data available
6 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

No data available

Flash point:

72 °F / 22 °C

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Method: closed cup
Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

Ignitable (see flash point)

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapor pressure:

No data available

Relative vapor density:

No data available

Relative density:

No data available

Density:

No data available

Solubility(ies)
Water solubility:

No data available

Partition coefficient: noctanol/water
Autoignition temperature:

Not applicable:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

Particle size:

Not applicable

SECTION 10. STABILITY AND REACTIVITY
7 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Reactivity
Chemical stability
Possibility of hazardous reactions:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Highly flammable liquid and vapor.
Vapors may form explosive mixture with air.
Can react with strong oxidizing agents.

Conditions to avoid
Incompatible materials
Hazardous decomposition
products:::

Heat, flames and sparks.
Oxidizing agents
No hazardous decomposition products are known.

SECTION 11. TOXICOLOGICAL INFORMATION
Information on likely routes of exposure
Inhalation
Skin contact
Ingestion
Eye contact
Acute toxicity
Not classified based on available information.
Components:
Ethanol:
Acute oral toxicity:

LD50 (Rat): > 5,000 mg/kg
Method: OECD Test Guideline 401

Acute inhalation toxicity:

LC50 (Rat): 124.7 mg/l
Exposure time: 4 h
Test atmosphere: vapor

Propylene glycol:
Acute oral toxicity:

LD50 (Rat): 22,000 mg/kg

Acute inhalation toxicity:

LC50 (Rat): > 44.9 mg/l
Exposure time: 4 h
Test atmosphere: dust/mist

Acute dermal toxicity:

LD50 (Rabbit): > 2,000 mg/kg
Assessment: The substance or mixture has no acute dermal
toxicity

Estradiol:
Acute oral toxicity:

LD50 (Rat): > 2,000 mg/kg

Acute toxicity (other routes of :administration)

LD50 (Rat): > 300 mg/kg
Application Route: Subcutaneous

Skin corrosion/irritation
Not classified based on available information.

8 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Components:
Ethanol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Propylene glycol:
Species
MethodResult:::RabbitOECD Test Guideline 404
No skin irritation

Serious eye damage/eye irritation
Causes serious eye irritation.
Components:
Ethanol:
SpeciesResult
Method:::RabbitIrritation to eyes, reversing within 21 days
OECD Test Guideline 405

Propylene glycol:
SpeciesResult
Method:::RabbitNo eye irritation
OECD Test Guideline 405

Estradiol:
Result:No eye irritation

Respiratory or skin sensitization
Skin sensitization
Not classified based on available information.
Respiratory sensitization
Not classified based on available information.
Components:
Ethanol:
Test Type
Routes of exposure
SpeciesResult::::Local lymph node assay (LLNA)
Skin contact
Mouse
negative

Propylene glycol:
Test Type
Routes of exposure
SpeciesResult::::Maximization Test
Skin contact
Guinea pig
negative
9 / 20SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

Estradiol:
Routes of exposure
Species
Assessment
ResultSDS Number:
10608695-00006

:
:
:
:

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Skin contact
Guinea pig
Does not cause skin sensitization.
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
Ethanol:
Genotoxicity in vitro:

Test Type: In vitro mammalian cell gene mutation test
Result: negative
Test Type: Bacterial reverse mutation assay (AMES)
Result: negative

Genotoxicity in vivo:

Test Type: Rodent dominant lethal test (germ cell) (in vivo)
Species: Mouse
Application Route: Ingestion
Result: equivocal

Propylene glycol:
Genotoxicity in vitro:

Test Type: Bacterial reverse mutation assay (AMES)
Result: negative
Test Type: Chromosome aberration test in vitro
Method: OECD Test Guideline 473
Result: negative

Genotoxicity in vivo:

Test Type: Mammalian erythrocyte micronucleus test (in vivo
cytogenetic assay)
Species: Mouse
Application Route: Intraperitoneal injection
Result: negative

Estradiol:
Genotoxicity in vitro:

Test Type: DNA damage and repair, unscheduled DNA synthesis in mammalian cells (in vitro)
Test system: mammalian cells
Result: positive
Test Type: Chromosome aberration test in vitro
Test system: mammalian cells
Result: positive
Test Type: Chromosomal aberration
Test system: mammalian cells
Result: positive
10 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

Genotoxicity in vivo

SDS Number:
10608695-00006:

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Test Type: Chromosomal aberration
Species: Rat
Cell type: Bone marrow
Result: negative
Test Type: Chromosomal aberration
Species: Mouse
Cell type: Bone marrow
Result: negative

Carcinogenicity
May cause cancer.
Components:
Propylene glycol:
Species
Application RouteExposure time
Result

:
:
:
:

Rat
Ingestion
2 Years
negative

Estradiol:
Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Mouse
Ingestion
24 Months
100 µg/kg
positive
female reproductive organs

Species
Application RouteExposure time
LOAEL
ResultTarget Organs

:
:
:
:
:
:

Rat
Subcutaneous
13 weeks
20 mg/kg body weight
positive
Endocrine system

Carcinogenicity - Assess: Positive evidence from human epidemiological studies
ment
IARC
No ingredient of this product present at levels greater than or equal to 0.1% isidentified as probable, possible or confirmed human carcinogen by IARC.
OSHA

No component of this product present at levels greater than or equal to 0.1% is
on OSHA’s list of regulated carcinogens.

NTP

Known to be human carcinogenEstradiol(Estrogens, Steroidal)

Reproductive toxicity
May damage fertility. May damage the unborn child.

11 / 2050-28-2

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Components:
Ethanol:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative

Propylene glycol:
Effects on fertility:

Test Type: Two-generation reproduction toxicity study
Species: Mouse
Application Route: Ingestion
Result: negative

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Mouse
Application Route: Ingestion
Result: negative

Estradiol:
Effects on fertility:

Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Ingestion
Fertility: LOAEL: 0.5 mg/kg body weight
Result: Effects on fertility.
Test Type: One-generation reproduction toxicity study
Species: Rat
Duration of Single Treatment: 90 d
Fertility: LOAEL: 0.69 mg/kg body weight
Result: Effects on fertility.
Test Type: Two-generation study
Species: Mouse
Application Route: Oral
Fertility: LOAEL: 0.1 mg/kg body weight
Result: Effects on fertility.

Effects on fetal development:

Test Type: Embryo-fetal development
Species: Mouse, female
Application Route: Subcutaneous
Teratogenicity: LOAEL: 4 mg/kg body weight
Symptoms: Malformations were observed.
Result: positive, Teratogenic effects.
Test Type: One-generation reproduction toxicity study
Species: Rat
Application Route: Subcutaneous
Teratogenicity: LOAEL: 2.5 µg/kg body weight
Symptoms: Reduced body weight
Result: positive, Embryotoxic effects and adverse effects on
the offspring were detected.
12 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Test Type: Embryo-fetal development
Species: Rat
Application Route: Subcutaneous
Developmental Toxicity: LOAEL: 0.2 mg/kg body weight
Symptoms: Early Resorptions / resorption rate., Reduced
number of viable fetuses., Reduced body weight
Result: Embryotoxic effects and adverse effects on theoffspring were detected only at high maternally toxic doses
Reproductive toxicity - Assessment:

May damage fertility. May damage the unborn child.

STOT-single exposure
Not classified based on available information.
STOT-repeated exposure
Causes damage to organs (Liver, Bone, Blood, Endocrine system) through prolonged or repeatedexposure.
Components:
Estradiol:
Target Organs
Assessment::

Liver, Bone, Blood, Endocrine system
Causes damage to organs through prolonged or repeatedexposure.

Ethanol:
Species
NOAEL
LOAEL
Application RouteExposure time

:
:
:
:
:

Rat
1,280 mg/kg
3,156 mg/kg
Ingestion
90 Days

Propylene glycol:
Species
NOAEL
Application RouteExposure time

:
:
:
:

Rat, male>= 1,700 mg/kg
Ingestion
2y

Estradiol:
Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Rat
>= 0.17 mg/kg
Ingestion
90 d
Mammary gland, Ovary, Uterus (including cervix), Liver, Bone,
Endocrine system, Blood, Testis

Repeated dose toxicity
Components:

13 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Estradiol:
Inhalation
Skin contact
Ingestion:::

Symptoms: tingling, Nose bleeding
Symptoms: Skin irritation, Redness, pruritis
Symptoms: Headache, Gastrointestinal disturbance, Dizziness, Vomiting, Diarrhea, water retention, liver functionchange, changes in libido, breast tenderness, menstrual irregularities

SECTION 12. ECOLOGICAL INFORMATION
Ecotoxicity
Components:
Ethanol:
Toxicity to fish:

LC50 (Pimephales promelas (fathead minnow)): > 1,000 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia (water flea)): > 1,000 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Chlorella vulgaris (Fresh water algae)): 275 mg/l
Exposure time: 72 h
EC10 (Chlorella vulgaris (Fresh water algae)): 11.5 mg/l
Exposure time: 72 h

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

Propylene glycol:
Toxicity to fish

NOEC (Daphnia magna (Water flea)): 9.6 mg/l
Exposure time: 9 d
EC50 (Pseudomonas putida): 6,500 mg/l
Exposure time: 16 h:

LC50 (Oncorhynchus mykiss (rainbow trout)): 40,613 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Ceriodaphnia dubia (water flea)): 18,340 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:

ErC50 (Skeletonema costatum (marine diatom)): 19,300 mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to daphnia and other :aquatic invertebrates (Chron-

NOEC (Ceriodaphnia dubia (water flea)): 13,020 mg/l
Exposure time: 7 d
14 / 20

SAFETY DATA SHEET
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Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

ic toxicity)
Toxicity to microorganisms:

NOEC (Pseudomonas putida): > 20,000 mg/l
Exposure time: 18 h

Estradiol:
Toxicity to fish:

LC50 (Oryzias latipes (Japanese medaka)): 3.9 mg/l
Exposure time: 96 h

Toxicity to daphnia and otheraquatic invertebrates:

EC50 (Daphnia magna (Water flea)): 2.7 mg/l
Exposure time: 48 h

Toxicity to algae/aquaticplants:NOEC (Pseudokirchneriella subcapitata (green algae)): 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201
EC50 (Pseudokirchneriella subcapitata (green algae)): > 1.7
mg/l
Exposure time: 72 h
Method: OECD Test Guideline 201

Toxicity to fish (Chronic toxicity):

Toxicity to daphnia and other :aquatic invertebrates (Chronic toxicity)
Toxicity to microorganisms:

NOEC (Oryzias latipes (Japanese medaka)): 0.000003 mg/l
Exposure time: 160 d
Method: OECD Test Guideline 210
NOEC (Daphnia magna (Water flea)): 0.2 mg/l
Exposure time: 21 d
EC50: > 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209
NOEC: 100 mg/l
Exposure time: 3 hTest Type: Respiration inhibition
Method: OECD Test Guideline 209

Persistence and degradability
Components:
Ethanol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 84 %Exposure time: 20 d

Propylene glycol:
Biodegradability:

Result: Readily biodegradable.
Biodegradation: 98.3 %Exposure time: 28 d
Method: OECD Test Guideline 301F
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SAFETY DATA SHEET
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Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

Estradiol:
Biodegradability

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022:

Result: rapidly degradable
Biodegradation: 84 %Exposure time: 24 hrs

Ethanol:
Partition coefficient: noctanol/water:log Pow: -0.35

Propylene glycol:
Partition coefficient: noctanol/water:log Pow: -1.07
Method: Regulation (EC) No. 440/2008, Annex, A.8

Estradiol:
Partition coefficient: noctanol/water:log Pow: 4.01:

log Koc: 3.81

Bioaccumulative potential
Components:

Mobility in soil
Components:
Estradiol:
Distribution among environmental compartments
Other adverse effects
No data available
SECTION 13. DISPOSAL CONSIDERATIONS
Disposal methods
Waste from residues:

Contaminated packaging:

Dispose of in accordance with local regulations.
Do not dispose of waste into sewer.
Empty containers should be taken to an approved waste
handling site for recycling or disposal.
Empty containers retain residue and can be dangerous.
Do not pressurize, cut, weld, braze, solder, drill, grind, or
expose such containers to heat, flame, sparks, or othersources of ignition. They may explode and cause injury and/or
death.
If not otherwise specified: Dispose of as unused product.

SECTION 14. TRANSPORT INFORMATIONInternational Regulations
UNRTDG
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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

UN number
Proper shipping nameClass
Packing group
LabelsEnvironmentally hazardous

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

:
:
:
:
:
:

UN 1170
ETHANOL SOLUTION
3
II
3
yes

:
:
:
:
:
:

UN 1170
Ethanol solution
3IIFlammable Liquids
364

:

353

IMDG-CodeUN number
Proper shipping name

:
:

Class
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:

UN 1170
ETHANOL SOLUTION(Estradiol)
3II
3F-E, S-D
yes

IATA-DGR
UN/ID No.
Proper shipping nameClass
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)

Transport in bulk according to Annex II of MARPOL 73/78 and the IBC CodeNot applicable for product as supplied.
Domestic regulation
49 CFR
UN/ID/NA number
Proper shipping nameClass
Packing group
LabelsERG Code
Marine pollutant

:
:
:
:
:
:
:

UN 1170
Ethanol solutions
3
II
FLAMMABLE LIQUID
127
yes(Estradiol)

Special precautions for user
The transport classification(s) provided herein are for informational purposes only, and solely
based upon the properties of the unpackaged material as it is described within this Safety Data
Sheet. Transportation classifications may vary by mode of transportation, package sizes, andvariations in regional or country regulations.
SECTION 15. REGULATORY INFORMATIONCERCLA Reportable Quantity
This material does not contain any components with a CERCLA RQ.
SARA 304 Extremely Hazardous Substances Reportable Quantity
This material does not contain any components with a section 304 EHS RQ.

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

SARA 302 Extremely Hazardous Substances Threshold Planning Quantity
This material does not contain any components with a section 302 EHS TPQ.
SARA 311/312 Hazards:

Flammable (gases, aerosols, liquids, or solids)
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity (single or repeated exposure)
Serious eye damage or eye irritation

SARA 313:

This material does not contain any chemical components withknown CAS numbers that exceed the threshold (De Minimis)
reporting levels established by SARA Title III, Section 313.

US State Regulations
Pennsylvania Right To Know
Ethanol
Water
Propylene glycol
Estradiol64-17-57732-18-5
57-55-6
50-28-2

California Prop. 65
WARNING: This product can expose you to chemicals including Estradiol, which is/are known to
the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.
California List of Hazardous Substances
Ethanol

64-17-5

California Permissible Exposure Limits for Chemical Contaminants
Ethanol

64-17-5

The ingredients of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

SECTION 16. OTHER INFORMATION
Further information

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SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

NFPA 704:

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022
HMIS® IV:

Flammability

HEALTH

3
Health20Special hazard*

3

FLAMMABILITY

3

PHYSICAL HAZARD

0

Instability

HMIS® ratings are based on a 0-4 rating
scale, with 0 representing minimal hazards or risks, and 4 representing significant hazards or risks. The "*" represents
a chronic hazard, while the "/" represents
the absence of a chronic hazard.

Full text of other abbreviations
ACGIH: USA. ACGIH Threshold Limit Values (TLV)
NIOSH REL
: USA. NIOSH Recommended Exposure Limits
OSHA Z-1: USA. Occupational Exposure Limits (OSHA) - Table Z-1 Limits for Air Contaminants
US WEEL: USA. Workplace Environmental Exposure Levels (WEEL)ACGIH / STEL
: Short-term exposure limit
NIOSH REL / TWA: Time-weighted average concentration for up to a 10-hour
workday during a 40-hour workweek
OSHA Z-1 / TWA: 8-hour time weighted average
US WEEL / TWA: 8-hr TWA
AIIC - Australian Inventory of Industrial Chemicals; ASTM - American Society for the Testing ofMaterials; bw - Body weight; CERCLA - Comprehensive Environmental Response, Compensation,and Liability Act; CMR - Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of theGerman Institute for Standardisation; DOT - Department of Transportation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with x% response; EHS - Extremely Hazardous Substance; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; HMIS - Hazardous Materials Identification System; IARC International Agency for Research on Cancer; IATA - International Air Transport Association; IBC- International Code for the Construction and Equipment of Ships carrying Dangerous Chemicals
in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime
Dangerous Goods; IMO - International Maritime Organization; ISHL - Industrial Safety and Health
Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to
50% of a test population (Median Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships; MSHA - Mine Safety and Health Administration; n.o.s. - Not Otherwise Specified; NFPA - National Fire Protection Association; NO(A)EC - No Observed (Adverse)
Effect Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable
Effect Loading Rate; NTP - National Toxicology Program; NZIoC - New Zealand Inventory of
19 / 20

SAFETY DATA SHEET
according to the OSHA Hazard Communication Standard

Estradiol Gel Formulation
Version
2.0

Revision Date:
09/30/2023

SDS Number:
10608695-00006

Date of last issue: 04/04/2023
Date of first issue: 02/08/2022

Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Officeof Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; RCRA - Resource Conservation and Recovery Act;REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RQ - Reportable
Quantity; SADT - Self-Accelerating Decomposition Temperature; SARA - Superfund Amendments and Reauthorization Act; SDS - Safety Data Sheet; TCSI - Taiwan Chemical SubstanceInventory; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act(United States); UN - United Nations; UNRTDG - United Nations Recommendations on theTransport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative

Sources of key data used tocompile the Material Safety
Data Sheet:Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Revision Date:

09/30/2023

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
The information provided in this Safety Data Sheet is correct to the best of our knowledge,
information and belief at the date of its publication. The information is designed only as a
guidance for safe handling, use, processing, storage, transportation, disposal and release andshall not be considered a warranty or quality specification of any type. The information provided
relates only to the specific material identified at the top of this SDS and may not be valid when the
SDS material is used in combination with any other materials or in any process, unless specified
in the text. Material users should review the information and recommendations in the specificcontext of their intended manner of handling, use, processing and storage, including anassessment of the appropriateness of the SDS material in the user’s end product, if applicable.
US / Z8

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